MICONAZOLE NITRATE- anti-fungal powder miconazole nitrate talc free powder 
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Topcare Miconazorb Anti Fungal Powder Talc Free

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

for the cure of most athlete's foot, jock itch and ringworm

Warnings

For external use only.

Do not use

on children 2 years of age unless directed by a doctor.

When using this product

avoid contact with the eyes

Stop and ask a doctor if

irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

Directions

Other information

Inactive ingredients

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

Questions?

call 1-866-964-0939

Principal Display Panel

TopCare

health

Miconazorb AF

ANTIFUNGAL POWDER

MICONAZOLE NITRATE 2%

NET WT 2.5 OZ (71g)

powder

MICONAZOLE NITRATE 
anti-fungal powder miconazole nitrate talc free powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-385
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE1.42 g  in 71 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
IMIDUREA (UNII: M629807ATL)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-385-2571 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/07/2017
Labeler - Topco Associates LLC (006935977)

Revised: 1/2023
Document Id: f3974966-74a3-acaf-e053-2995a90a2404
Set id: 0afaf920-e30a-4a7c-a19e-558b31ae7e58
Version: 5
Effective Time: 20230131
 
Topco Associates LLC